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Contrast agents containing gadolinium: Deposits in the brain and other tissues

Date 2017.12.15
Active substance gadolinium

15.12.2017 - realisation of the EU Commission's implementing decision

The Federal Institute for Drugs and Medical Devices (BfArM) issues information on the realisation of the EU Commission's implementing decision following the European Medicines Agency's (EMA) scientific review of contrast agents containing gadolinium. It is confirmed that the use of some linear gadolinium contrast agents used for MRI imaging is restricted and that the marketing authorisations of other linear gadolinium contrast agents shall be suspended as of 28 February 2018.

31.07.2017 - CMDh opinion

The Federal Institute for Drugs and Medical Devices (BfArM) issues information on the fact that the European Medicines Agency (EMA) has concluded its review of contrast agents containing gadolinium and confirms that the use of some linear gadolinium contrast agents used in MRI body scans is restricted and marketing authorisations of other linear contrast agents containing gadolinium shall be suspended.

10.04.2017 - update

Some of the marketing authorisation holders affected by the recommendation of the Pharmacovigilance Risk Assessment Committee (PRAC) of March 2017, have requested a renewed assessment of the available data. After receipt of the reasonings for these requests, the PRAC will launch a renewed assessment which will presumably be completed in July of 2017.

14.03.2017 - under evaluation

The Federal Institute for Drugs and Medical Devices (BfArM) issues information on the recommendation of the Pharmacovigilance Risk Assessment Committee (PRAC) to rule suspension of the marketing authorisations of four linear gadolinium contrast agents.

18.03.2016 - procedure started

The BfArM issues information on the initiation of a European safety review regarding contrast agents containing gadolinium which are used in magnetic resonance imaging (MRI).

To the risk assessment procedure (available in German only)

For details on the procedure please click on the following link to the homepage of the European Medicines Agency (EMA):

Gadolinium-containing contrast agents2